Bioavailability of Orally Ingested Vitamin C

NCT05183880 | Withdrawn

• 1 other identifier: 21-10-20-B-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if crystalline vitamin C supplementation can acutely increase skeletal muscle vitamin C concentrations and if this can be potentiated by administering vitamin C using Phosphycell™ Technology - a phosphatidylcholine-lipid encapsulation technology.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Skeletal muscle vitamin C concentrations

  Skeletal muscle vitamin C concentrations 6 hours after vitamin C ingestion will be measured using HPLC and compared to baseline

  6 hours after vitamin C ingestion

• Skeletal muscle vitamin C concentrations

  Skeletal muscle vitamin C concentrations 12 hours after vitamin C ingestion will be measured using HPLC and compared to baseline and 6 hours after vitamin C ingestion

  12 hours after vitamin C ingestion

Secondary Outcomes (4)

• Blood plasma vitamin C concentrations

  24 hours after vitamin C ingestion

• White blood cell vitamin C concentrations

  6 hours after vitamin C ingestion

• White blood cell vitamin C concentrations

  24 hours after vitamin C ingestion

• Cardiovascular function

  24 hours after vitamin C ingestion

Study Arms (2)

Crystalline vitamin C supplementation

ACTIVE COMPARATOR

1000 mg of vitamin C ingested in crystalline form

Dietary Supplement: Crystalline vitamin C

Phosphatidylcholine-lipid encapsulated vitamin C supplementation

EXPERIMENTAL

1000 mg of vitamin C ingested in phosphatidylcholine-lipid encapsulated form

Dietary Supplement: Phosphatidylcholine-lipid encapsulated vitamin C

Interventions

Phosphatidylcholine-lipid encapsulated vitamin C DIETARY_SUPPLEMENT

Ingesting 1000 mg of vitamin C in phosphatidylcholine-lipid encapsulated form

Phosphatidylcholine-lipid encapsulated vitamin C supplementation

Crystalline vitamin C DIETARY_SUPPLEMENT

Ingesting 1000 mg of vitamin C in crystalline form

Crystalline vitamin C supplementation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) 18.5 - 30 kg/m2
• Age 18 - 40
• Non-smoker

You may not qualify if:

• Body mass index (BMI) \< 18.5 or \> 30 kg/m2
• Age \< 18 or \> 40
• Smoking
• Cardiovascular disease
• Hypertension (≥ 140/90 mmHg)
• Metabolic disease
• Medications known to affect vitamin C metabolism
• A known vitamin C deficiency
• Less than 2 hours per week of physical activity or following a structured exercise training program.
• Routine use of vitamin supplements

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (1)

Sport and Health Sciences

Exeter, Devon, EX1 2LU, United Kingdom

Location

Study Officials

• Francis Stephens

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 11, 2022
• Study Start: November 26, 2021
• Primary Completion: November 26, 2022
• Study Completion: November 26, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

GB (1)